The efficacy and safety of gemcitabine plus cisplatin regimen for patients with advanced urothelial carcinoma after failure of M-VAC regimen.

BACKGROUND

Our aim was to study the efficacy and safety of combination chemotherapy with gemcitabine plus cisplatin (GC) for patients with advanced urothelial carcinoma (UC) after failure of methotrexate, vinblastin, adriamycin, and cisplatin (M-VAC) chemotherapy.

METHODS

We studied a total of 33 patients with advanced UC. All patients were treated with M-VAC with a mean of 3.2 courses per patient and had showed disease progression or no response. Clinical and pathological features were correlated to survival rates, and the incidence and degree of toxicities were also retrospectively reviewed.

RESULTS

A total of 132 courses of GC with a mean of 4.0 courses per patients were undergone. Two (6.0%) complete responses and 11 (33.3%) partial responses produced an overall response rate of 39.4%. In 55 assessable lesions, there were 2 (4%) complete responses, 13 (23%) partial responses, 31 (55%) with stable disease, and 10 (18%) with progressive disease. Overall, mean of survival time after GC chemotherapy was 10.5 months (range, 3.0-22.9 months). In univariate analysis, the patients with higher serum hemoglobin or single metastasis or no liver metastasis tended to survive longer than those with lower hemoglobin or multiple metastases or existence of liver metastasis. Although grade 3-4 neutropenia was seen in 22 patients (66.7%) and grade 3-4 thrombocytopenia was seen in 10 patients (30.3%), fatal side effects were not observed.

CONCLUSIONS

The combination chemotherapy with GC seems feasible with no severe side effects and may provide a survival benefit for patients with advanced UC after failure of M-VAC chemotherapy.